CN109394732A - Sinomenine enteric positions osmotic pump controlled release capsule and preparation method thereof - Google Patents
Sinomenine enteric positions osmotic pump controlled release capsule and preparation method thereof Download PDFInfo
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- CN109394732A CN109394732A CN201710732454.1A CN201710732454A CN109394732A CN 109394732 A CN109394732 A CN 109394732A CN 201710732454 A CN201710732454 A CN 201710732454A CN 109394732 A CN109394732 A CN 109394732A
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- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
- A61K31/00—Medicinal preparations containing organic active ingredients
- A61K31/33—Heterocyclic compounds
- A61K31/395—Heterocyclic compounds having nitrogen as a ring hetero atom, e.g. guanethidine or rifamycins
- A61K31/435—Heterocyclic compounds having nitrogen as a ring hetero atom, e.g. guanethidine or rifamycins having six-membered rings with one nitrogen as the only ring hetero atom
- A61K31/47—Quinolines; Isoquinolines
- A61K31/485—Morphinan derivatives, e.g. morphine, codeine
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- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
- A61K47/00—Medicinal preparations characterised by the non-active ingredients used, e.g. carriers or inert additives; Targeting or modifying agents chemically bound to the active ingredient
- A61K47/06—Organic compounds, e.g. natural or synthetic hydrocarbons, polyolefins, mineral oil, petrolatum or ozokerite
- A61K47/08—Organic compounds, e.g. natural or synthetic hydrocarbons, polyolefins, mineral oil, petrolatum or ozokerite containing oxygen, e.g. ethers, acetals, ketones, quinones, aldehydes, peroxides
- A61K47/10—Alcohols; Phenols; Salts thereof, e.g. glycerol; Polyethylene glycols [PEG]; Poloxamers; PEG/POE alkyl ethers
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- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
- A61K47/00—Medicinal preparations characterised by the non-active ingredients used, e.g. carriers or inert additives; Targeting or modifying agents chemically bound to the active ingredient
- A61K47/30—Macromolecular organic or inorganic compounds, e.g. inorganic polyphosphates
- A61K47/32—Macromolecular compounds obtained by reactions only involving carbon-to-carbon unsaturated bonds, e.g. carbomers, poly(meth)acrylates, or polyvinyl pyrrolidone
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- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
- A61K47/00—Medicinal preparations characterised by the non-active ingredients used, e.g. carriers or inert additives; Targeting or modifying agents chemically bound to the active ingredient
- A61K47/30—Macromolecular organic or inorganic compounds, e.g. inorganic polyphosphates
- A61K47/36—Polysaccharides; Derivatives thereof, e.g. gums, starch, alginate, dextrin, hyaluronic acid, chitosan, inulin, agar or pectin
- A61K47/38—Cellulose; Derivatives thereof
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- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
- A61K9/00—Medicinal preparations characterised by special physical form
- A61K9/48—Preparations in capsules, e.g. of gelatin, of chocolate
- A61K9/4808—Preparations in capsules, e.g. of gelatin, of chocolate characterised by the form of the capsule or the structure of the filling; Capsules containing small tablets; Capsules with outer layer for immediate drug release
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- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
- A61K9/00—Medicinal preparations characterised by special physical form
- A61K9/48—Preparations in capsules, e.g. of gelatin, of chocolate
- A61K9/4816—Wall or shell material
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Abstract
The present invention relates to Sinomenine enteric positioning osmotic pump controlled release capsules and preparation method thereof, which is made of the content that enteric positions osmotic pump controlled release capsule case and is loaded in the inside.This enteric of the present invention positions osmotic pump controlled release capsule case, it is prepared by cellulose acetate, enteric pore-foaming agent and plasticizer, and there is release hole in capsule shells, it can be used for filling chemicals, Chinese medicine, biological medicine etc., it can control drug release rate, and achieve the effect that small intestine positioning release.Content according to the present invention is made of Sinomenine powder, penetration enhancer, rush osmopolymer and other pharmaceutic adjuvants.Sinomenine enteric positioning osmotic pump controlled release capsule can realize the enteron aisle controlled release of Sinomenine, and simple process, equipment requirement are low, easily operated, are suitable for industrialized production.
Description
Technical field
The present invention relates to technical field of medicine, position osmotic pump controlled-releasing more particularly, to Sinomenine enteric
Capsule and preparation method thereof.
Background technique
Sinomenine is Chinese medicine menispermaceous plants caulis sinomenii, seeks principle active component sinomenium acutum in the plant roots and stems such as wind rattan
The hydrochloride of alkali can be used for treating the various rheumatoid diseases such as rheumatism, rheumatoid arthritis and arrhythmia cordis.Sinomenine is oral
Bioavilability is low, and patient needs chronic oral administration, while having certain GI irritation, release histamine to cause fash etc. is secondary to make
With.Have enteric coated tablet of Zhengqing Fengtongning, sustained release tablets and injection etc. on domestic market.The common enteric coatel tablets of Sinomenine can
Toxicity is reduced, but initial stage of taking medicine is interior for a period of time, blood concentration is very low, and rear quick release, blood concentration increases suddenly, out
An existing apparent peak value, it cannot be guaranteed that blood concentration is steady, and medicining times are more, patient's poor compliance;Sinomenine
When there is gel skeleton sustained release tablets steady internal blood concentration, administration number of times reduction, drug effect to continue compared with other ordinary preparations
Between it is long the features such as, but clinical application finds that its toxicity is more obvious, be mainly shown as more serious gastrointestinal allergies reaction,
Especially to the stimulation of stomach lining.Therefore, its enteric positioning slow/controlled release preparation is developed, drug effect can be made lasting, reduce clothes
Medicine number mitigates GI irritation, improves the compliance and safety of patient medication.
Oros preparation is in a manner of its unique drug release and stable rate of releasing drug causes the common concern of people, is
A kind of slow/controlled release preparation ideal in controlled release formulations for oral administration so far.The most common are osmotic pumps at present in osmotic pump preparation
Tablet.The oral osmotic pump-type preparation researched and developed at present has single chamber and multicell osmotic pump tablet.But either single chamber is still more
Chamber osmotic pump piece all has the disadvantages of the high requirements on the equipment, preparation process are complicated, drug limiting factor is more, seriously limits infiltration
The development of pump preparation thoroughly.
Osmotic pumps capsule is the novel controlled release preparation for generating capsule shells in conjunction with osmotic pump preparation, with osmotic tablet
Compared to apparent advantage: (1) preparation process is relatively easy.Osmotic pumps capsule need to only select suitable capsule material and technique
Preparation osmotic pumps capsule shells are mixed drug with certain penetration enhancer by the preparation principle of capsule, by granulation or not
Granulation, pours into capsule shells, osmotic pumps capsule can be obtained after sealing.Drug can be separated with capsule shells in this osmotic pump preparation
It is prepared separately, tabletting and enrobing processes is not necessarily in preparation process.(2) medicament selection is flexible.Osmotic tablet is due to by tablet body
The limitation of product, drug solubility, therefore it is generally suitable for that dosage is small, the drug of solubility moderate (50~300gL-1 water), agent
The drug that amount is big, solubility is too high or too low, is unsuitable for being prepared into osmotic pump tablet.And osmotic pumps capsule can pass through selection
Different capsule shells sizes, can be by adjusting in capsule shells to the drug of different solubilities to arrange the drug content of drug
The pH value of environment or with ion situation selects different release hole sizes to be adjusted, regulating medicine rate of release it is fast
Slowly.Therefore osmotic pumps capsule can make the range of choice of drug wider than osmotic pump tablet, to be some be not suitable for that osmotic pump tablet is made
The medicine preparation of agent provides new method at osmotic pump preparation.(3) prescription is simple.Tablet is because of its complicated technical process, certainly
Determine that the auxiliary materials such as certain adhesive, disintegrating agent, lubricant must be added in the prescription of tablet, and capsule preparation simple process,
, can be filling without tabletting, therefore auxiliary material selection is greatly simplified, cost is saved, technological operation is simplified, improves production efficiency.
Common permeable pump capsule has the following problems during oral delivery: although normal oral osmotic pumps capsule energy
Constant speed release medicine, but due to osmotic pump preparation since in contact water environment be discharge drug, it is difficult to what is avoided causes mainly to exist
Intestinal absorption, under one's belt it is unstable, there is the drug of stronger gastric irritation to discharge under one's belt, it is difficult to ensure its constant absorption.Therefore, have
Necessity carries out the research of enteric positioning osmotic pumps capsule according to pharmaceutical properties.
Although current prior art realizes the positioning release of osmotic pump preparation, generally use in the semi-transparent of osmotic pump preparation
Film outsourcing separation layer and enteric layer reach small intestine positioning controlled-release effect, such method preparation process by way of multiple coatings
It is excessively complicated, and processing step is cumbersome, uncontrollable factor is more, and high production cost is unfavorable for industrialized production.
Summary of the invention:
The purpose of the present invention is overcoming the above-mentioned deficiency of the prior art, a kind of Sinomenine of enteric positioning release is provided
Controlled release capsule, solution Sinomenine enteric coated preparations are unable to constant release and osmotic pump preparation and start drug release cause in stomach
Make the technical problems such as gastric irritation, be allowed to realize the enteron aisle controlled release of Sinomenine, drug is avoided to be discharged too early in stomach to shadow
It rings drug effect or generates side effect, blood concentration can be maintained in the long period.In addition, the technology can be used as a variety of shakinesses under one's belt
Basis that is fixed, having stronger gastric irritation and mainly realize enteron aisle controlled release in the drug of intestinal absorption, and this preparation method can be easy, big
Enteric positioning osmotic pumps capsule is measured and stably obtained, its industrialization is helped to realize.
The object of the present invention is achieved like this: the present invention is by with the capsule cap of release hole, capsule body and being loaded in
The pharmacological active substance and auxiliary material of the inside form.Sinomenine enteric of the present invention positioning osmotic pumps capsule it by with enteric half
Capsule body, capsule cap and the content composition for being loaded in the inside of permeable membrane property, the capsule body and capsule cap are to dip in glue
Blank-making technology is cut, arrangement obtains, and makes a call to a release hole at the top of capsule cap, and with enteric glue sealing of hole, will by pulling out shell
Content is loaded directly in capsule body with powder or particle form, and capsule cap is fastened and sealed with utricule;The content
Including pharmacological active substance, osmotic pressure active material, promote osmopolymer, acid cosolvent, weight percent are as follows: pharmacology is living
Property substance 5%-30%, osmotic pressure active material 10%-50%, promote osmopolymer 10-30%, acid cosolvent 10%-
30%, the release hole is to make a call to the aperture of a diameter 0.5-1.2mm at the top of capsule cap.
Above-mentioned enteric positions osmotic pump controlled release capsule case, it is characterised in that: is made of capsule cap and utricule, and in capsule shells
There is release hole on top, release the drug aperture diameter range: 0.1~1.5mm.Shell is pulled out by dipping in adhesive process, is cut, is arranged to get intestines
Molten positioning osmotic pumps capsule shells.Capsule material liquid is made of filmogen, enteric pore-foaming agent and plasticizer etc..Enteric by weight percentage
Positioning osmotic pump controlled release capsule case is at being grouped as:
Filmogen 2~50%
Enteric pore-foaming agent 0.5~50%
Plasticizer 0~50%
Filmogen described in above-mentioned preparation method is in cellulose acetate, ethyl cellulose, methylcellulose
One or more of mixtures;Enteric pore-foaming agent is selected from the first and second cellulose of carboxylic (CMEC), cellulose acetate phthalate in composition
(CAP), polyvinyl alcohol phthalate ester (PVAP), methacrylic acid copolymer, cellulose acetate benzenetricarboxylic acid ester (CAT), hydroxypropyl first are fine
Tie up combination one or more of in plain phthalate ester (HPMCP), Eudragit E uS100, EuL100 etc..Plasticizer be selected from glycerol,
Propylene glycol, polyethylene glycols, triethyl citrate, repefral, diethyl phthalate, phthalic acid two
The mixtures of monooctyl ester, dimethoxyethyl phthalate, the one or more of triacetyl glycerine.Solvent is propyl alcohol, isopropyl
Alcohol, propylene glycol, methanol, ethyl alcohol, water one or more mixture.
Conventional capsule shells preparation method preparation can be used in capsule shells described in above-mentioned preparation method, with sharp on softgel shell
The release hole of light, machinery or proper method preparation certain pore size, it is one of the preparation method comprises the following steps: by the filmogen of recipe quantity
It is dissolved in solvent with enteric pore-foaming agent, plasticizer, by dipping in adhesive process base, pulls out shell, cutting, arrangement after dry, use laser
Or proper method prepares suitable release hole, seals release hole with enteric glue and positions osmotic pump controlled release capsule to get enteric
Shell.
Any part of capsule shells described in above-mentioned preparation method can prepare certain hole with laser, machinery or proper method
The release hole of diameter, the number of release hole are 1~1000, and drug release aperture is 0.01~5.0mm.Release hole can use enteric glue
Liquid is sealed against, to prevent drug leakage, the joint filling material are as follows: the first and second cellulose of carboxylic (CMEC), cellulose acetate phthalate
(CAP), polyvinyl alcohol phthalate ester (PVAP), methacrylic acid copolymer, cellulose acetate benzenetricarboxylic acid ester (CAT), hydroxypropyl first are fine
It ties up one or more of in plain phthalate ester (HPMCP), Eudragit E uS100, EuL100 etc..
The osmotic pressure active material described in above-mentioned preparation method is selected from mannitol, sorbierite, xylitol, sugarcane
Sugar, lactose, fructose, glucose, sodium chloride, potassium chloride, magnesium chloride, calcium chloride, sodium phosphate, magnesium sulfate, calcium sulfate, potassium sulfate,
One or more of sodium citrate, potassium acetate or sodium acetate.The rush osmopolymer be selected from molecular weight be 100000~
500000 polyoxyethylene or povidone or Arabic gum or one or more of sodium alginate or hydroxypropyl methylcellulose.It is described
Acid cosolvent be selected from one or more of glycine, tartaric acid, citric acid.
Above-mentioned enteric positions osmotic pump controlled release capsule case, it is characterised in that: cellulose acetate, enteric material, PEG6000
Ratio of components is 10: 2: 1.5.
The enteric positions osmotic pump controlled release capsule, and the composition of prepared glue is it is characterized by: cellulose acetate
40g, hypromellose phthalate 8g, PEG6000 6g, acetone 500ML and appropriate amount of water are formed.
Above-mentioned osmotic pump controlled release capsule preparation, it is characterised in that: by pharmacological active substance, osmotic pressure active material, promote to seep
The auxiliary materials such as saturating polymer, acid cosolvent cross 80 meshes, weigh the above substance by recipe quantity, are uniformly mixed, direct using powder
Filling, wet granulation or dry granulation technology pour into osmotic pump controlled release capsule, and capsule cap is held in outside capsule body, while using capsule material
Fluid-tight mouth, is dried at room temperature.
The invention has the advantages that prepared by the method Sinomenine enteric positioning osmotic pump controlled release capsule and common
Capsule is compared, this enteric positions osmotic pumps capsule and do not dissolve in water, simulated gastric fluid, simulated intestinal fluid, the water in simulated intestinal fluid
Equal small molecule solutions can enter capsule through softgel shell, and drug molecule cannot penetrate capsule shells, but as core-clad material dissolves, it is interior
Portion's osmotic pressure increases, and drug can be released under the action of interior exosmosis pressure difference by small delivery aperture.Therefore, drug and auxiliary material
Mixing is packed into the capsule, and the rate of release of drug is only by the control of osmotic pressure inside and outside softgel shell, not by the shadow of external environment
It rings, drug release is slow and constant, and drug effect is lasting, curative effect is stable, toxic side effect is small.
Detailed description of the invention:
Fig. 1 is the outside drawing of enteric positioning osmotic pump controlled release capsule case of the invention
Fig. 2 is that Sinomenine enteric positions the type of osmotic pump controlled release capsule osmotic pressure active material to drug release
It influences
Fig. 3 is that Sinomenine enteric positions osmotic pump controlled release capsule mannitol-lactose dosage to the shadow of drug release
It rings
Fig. 4 is shadow of the type to drug release that Sinomenine enteric positions that osmotic pump controlled release capsule promotees osmopolymer
It rings
Specific embodiment:
The preparation of 1 Sinomenine enteric of embodiment positioning osmotic pump controlled release capsule
Capsule shells prescription:
Preparation process:
The preparation of capsule shells:
(1) it prepares capsule liquid: since PEG class is water-soluble material, certain water is first added when preparing, it is dissolved;
Standing eliminates bubble.
(2) it carries out dipping in glue with dipping in adhesive process, when dipping in the certain number of glue, pulls out shell, cut, arrange, at the top of capsule cap
A release hole is made a call to, and positions osmotic pump controlled release capsule case with enteric glue sealing of hole to get enteric.
The preparation of Sinomenine enteric positioning osmotic pump controlled release capsule
(1) main ingredient and auxiliary material powder of 80 meshes were weighed according to recipe quantity precision respectively, was uniformly mixed;
(2) the content powder of recipe quantity is loaded to enteric and is positioned in infiltration capsule shells, by capsule body and capsule cap button
Merge and is sealed with capsule material liquid.
The preparation of 2 Sinomenine enteric of embodiment positioning osmotic pump controlled release capsule
Capsule shells prescription:
Preparation process:
The preparation of capsule shells is the same as example 1.
Sinomenine enteric positions the preparation of osmotic pump controlled release capsule with example 1.
The preparation of 3 Sinomenine enteric of embodiment positioning osmotic pump controlled release capsule
Capsule shells prescription:
Preparation process:
The preparation of capsule shells is the same as example 1.
Sinomenine enteric positions the preparation of osmotic pump controlled release capsule with example 1.
The preparation of 4 Sinomenine enteric of embodiment positioning osmotic pump controlled release capsule
Capsule shells prescription:
Preparation process:
The preparation of capsule shells is the same as example 1.
Sinomenine enteric positions the preparation of osmotic pump controlled release capsule with example 1.
The preparation of 5 Sinomenine enteric of embodiment positioning osmotic pump controlled release capsule
Capsule shells prescription:
Preparation process:
The preparation of capsule shells is the same as example 1.
Sinomenine enteric positions the preparation of osmotic pump controlled release capsule with example 1.
The preparation of 6 Sinomenine enteric of embodiment positioning osmotic pump controlled release capsule
Capsule shells prescription:
Preparation process:
The preparation of capsule shells is the same as example 1.
Sinomenine enteric positions the preparation of osmotic pump controlled release capsule with example 1.
Claims (9)
1. Sinomenine enteric positions osmotic pump controlled release capsule preparation, it is characterised in that: it positions osmotic pump controlled-releasing by enteric
Capsule shells and the content composition for being loaded in the inside, the capsule body and capsule cap of the enteric positioning osmotic pump controlled release capsule case
It is, by pulling out shell, to be cut, arrangement obtains, and makes a call to a release hole at the top of capsule cap, and with enteric glue with dipping in glue blank-making technology
Sealing of hole, is loaded directly in capsule body for content with powder or particle form, and capsule cap is fastened and sealed with utricule;Described
Content includes pharmacological active substance, osmotic pressure active material, promotees osmopolymer, acid cosolvent, weight percent are as follows:
Pharmacological active substance 5%-30%, osmotic pressure active material 10%-50% promote osmopolymer 10-30%, acid cosolvent
10%-30%, the release hole are to make a call to the aperture of a diameter 0.5-1.2mm at the top of capsule cap.
2. enteric according to claim 1 positions osmotic pump controlled release capsule case, it is characterised in that: by capsule cap and utricule group
At, and have release hole on capsule shells top, release the drug aperture diameter range: 0.1~1.5mm.Shell is pulled out by dipping in adhesive process, is cut
It cuts, arranges and position osmotic pumps capsule shells to get enteric.Capsule material liquid is made of filmogen, enteric pore-foaming agent and plasticizer etc..It presses
Weight percent enteric positions osmotic pump controlled release capsule case at being grouped as:
Filmogen 2~50%
Enteric pore-foaming agent 0.5~50%
Plasticizer 0~50%.
3. enteric according to claim 2 positions osmotic pump controlled release capsule case, it is characterised in that: filmogen selects in composition
From the mixture of one or more of cellulose acetate, ethyl cellulose, methylcellulose;Enteric pore-foaming agent is selected from composition
The first and second cellulose of carboxylic (CMEC), cellulose acetate phthalate (CAP), polyvinyl alcohol phthalate ester (PVAP), methacrylic acid copolymer
Object, cellulose acetate benzenetricarboxylic acid ester (CAT), hypromellose phthalate (HPMCP), Eudragit E uS100, EuL100
One or more of combination in.Plasticizer is selected from glycerol, propylene glycol, polyethylene glycols, triethyl citrate, phthalic acid
Dimethyl ester, diethyl phthalate, dioctyl phthalate, dimethoxyethyl phthalate, triacetyl glycerine
One or more of mixtures.Solvent be propyl alcohol, isopropanol, propylene glycol, methanol, ethyl alcohol, water one or more mixture.
4. enteric according to claim 2 positions osmotic pump controlled release capsule case, it is characterised in that: any part of capsule shells
It can be 1~1000 with the release hole of laser, machinery or proper method preparation certain pore size, the number of release hole, release the drug aperture
For 0.01~5.0mm.Release hole can be sealed against using enteric glue, to prevent drug leakage, the joint filling material are as follows: carboxylic first and second
Cellulose (CMEC), cellulose acetate phthalate (CAP), polyvinyl alcohol phthalate ester (PVAP), methacrylic acid copolymer acetic acid
It is a kind of in cellulose benzenetricarboxylic acid ester (CAT), hypromellose phthalate (HPMCP), Eudragit E uS100, EuL100 etc.
Or it is several.
5. enteric according to claim 2 positions osmotic pump controlled release capsule case, it is characterised in that: cellulose acetate, enteric
Material, PEG6000 ratio of components are 10: 2: 1.5.
6. enteric according to claim 2 positions osmotic pump controlled release capsule case, the composition of prepared glue it is characterized by:
Cellulose acetate 40g, hypromellose phthalate 8g, PEG6000 6g, acetone 500ML and appropriate amount of water are formed.
7. enteric according to claim 1 positions osmotic pump controlled release capsule, it is characterised in that: the acid cosolvent choosing
From one or more of glycine, tartaric acid, citric acid.
8. Sinomenine enteric according to claim 1 positions osmotic pump controlled release capsule preparation, it is characterised in that: described
Osmotic pressure active material, be selected from mannitol, sorbierite, xylitol, sucrose, lactose, fructose, glucose, sodium chloride, chlorination
Potassium, magnesium chloride, calcium chloride, sodium phosphate, magnesium sulfate, calcium sulfate, one of potassium sulfate, sodium citrate, potassium acetate or sodium acetate
Or it is several.The rush osmopolymer is selected from the polyoxyethylene that molecular weight is 100000~500000 or povidone or Arab
Glue or one or more of sodium alginate or hydroxypropyl methylcellulose.
9. Sinomenine enteric positions osmotic pump controlled release capsule preparation according to claim 1, it is characterised in that: by pharmacology
Active material, osmotic pressure active material promote the auxiliary materials such as osmopolymer, acid cosolvent and cross 80 meshes, by recipe quantity weigh with
Upper substance is uniformly mixed, and is poured into osmotic pump controlled release capsule using powder directly filling, wet granulation or dry granulation technology,
Capsule cap is held in outside capsule body, while with capsule material fluid-tight mouth, being dried at room temperature.
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Cited By (1)
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CN111991364A (en) * | 2020-09-03 | 2020-11-27 | 四川省百草生物药业有限公司 | Lomerizine hydrochloride osmotic pump tablet and preparation method thereof |
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